imiquimod cream in treating patients with basal cell skin cancer

Conditions: Non-melanomatous Skin Cancer

Summary: rationale: biological therapies, such as imiquimod cream, work in different ways to stimulate the immune system and stop tumor cells from growing. purpose: this randomized phase i trial is studying how well imiquimod cream works in treating patients with basal cell skin cancer.

objectives: primary * compare levels of apoptosis in patients with basal cell skin cancer treated with vs without imiquimod 5% cream. secondary * compare levels of apoptosis in patients treated with this drug on two different administration schedules. outline: this is a randomized, double-blind, placebo-controlled, parallel-group study. patients undergo fine needle aspiration and punch biopsies of the target lesion. patients are then randomized to 1 of 8 treatment arms and begin therapy within 30 days after biopsy. * arm i: patients apply topical imiquimod to the target lesion once every 12 hours on days 1 and 2 for a total of 4 doses. * arm ii: patients apply topical placebo to the target lesion once every 12 hours on days 1 and 2 for a total of 4 doses. * arm iii: patients apply topical imiquimod to the target lesion once every 24 hours on days 1-4 for a total of 4 doses. * arm iv: patients apply topical placebo to the target lesion once every 24 hours on days 1-4 for a total of 4 doses. * arm v: patients apply topical imiquimod to the target lesion once every 12 hours on days 1-4 for a total of 8 doses. * arm vi: patients apply topical placebo to the target lesion once every 12 hours on days 1-4 for a total of 8 doses. * arm vii: patients apply topical imiquimod to the target lesion once every 24 hours on days 1-8 for a total of 8 doses. * arm viii: patients apply topical placebo to the target lesion every 24 hours on days 1-8 for a total of 8 doses. all patients undergo excision of the target tumor within 18-30 hours after the last topical treatment. patients are followed at 7-14 days. projected accrual: a total of 48 patients (8 per treatment arm and 4 per placebo arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed basal cell skin cancer * superficial or nodular disease * no aggressive disease * at least 1 lesion at least 7 mm in diameter that meets the following criteria: * primary tumor (no recurrent or previously treated disease) * located on the scalp, face (including ears), trunk, or proximal extremities * qualifies for surgical excision as primary therapy patient characteristics: age * 18 and over performance status * not specified life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified cardiovascular * no evidence of a clinically significant or unstable medical condition that would adversely affect blood circulation other * no dermatological disease (e.g., psoriasis or eczema) at the treatment site that may be exacerbated by treatment with imiquimod or interfere with examination * no febrile viral infection within the past 4 weeks * no evidence of a clinically significant or unstable medical condition that would adversely affect immune function prior concurrent therapy: biologic therapy * more than 4 weeks since prior interferon, interferon inducers, or immunomodulators * no concurrent interferon, interferon inducers, or immunomodulators chemotherapy * more than 6 months since prior anticancer chemotherapy * no concurrent anticancer chemotherapy endocrine therapy * more than 4 weeks since prior oral or inhaled (more than 600 mcg/day for fluticasone or equivalent) corticosteroids * more than 4 weeks since prior topical steroids to the target tumor * concurrent topical steroids in non-target areas are allowed provided amount used is ≤ 2 g of fluorinated steroids daily for \> 1 week or 6 g of beclomethasone for \> 1 week * no concurrent oral or inhaled corticosteroids radiotherapy * not specified surgery * more than 4 months since prior biopsy other * more than 4 weeks since prior immunosuppressive therapies * more than 4 weeks since prior cytotoxic or investigational drugs * no concurrent immunosuppressive therapies * no other concurrent cytotoxic or investigational drugs

Keywords: basal cell carcinoma of the skin